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About the Regulatory Profession

The regulatory function is vital in making safe and effective healthcare products available worldwide. Individuals who ensure regulatory compliance and prepare submissions, as well as those whose main job function is clinical affairs or quality assurance are all considered regulatory professionals.

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One of our most valuable contributions to the profession is the Regulatory Code of Ethics. The Code of Ethics provides regulatory professionals with core values that hold them to the highest standards of professional conduct.

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US regulators fought back Thursday against allegations that the US Food and Drug Administration (FDA) is stifling the innovation of mobile medical applications and other mobile devices by developing frameworks to regulate them, with one agency witness telling legislators that they are trying to walk a fine line between supporting innovation and protecting the public.

Background

The House Energy and Commerce Committee is in the midst of the three-day meeting regarding FDA's regulation of mobile medical applications, which range from simple applications like those that record a patient's weight, to more complex ones that track disease progression and make recommendations for treatment.

To accommodate the range of mobile medical applications-basically an application that runs on a smartphone or tablet--FDA issued a&nbsp;framework&nbsp;it published in the form of a draft guidance document in 2011.

Its authority to regulate the applications, which are seen as medical devices, comes at its most basic level from the&nbsp;Federal Food, Drug and Cosmetic Act (FD&amp;C Act)&nbsp;as amended under the 1976&nbsp;Medical Device Amendments&nbsp;and subsequent legislation.

Under the&nbsp;FD&amp;C Act, medical devices are defined as being any "instrument, apparatus, implement, machine, contrivance, implant,&nbsp;in vitro&nbsp;reagent, or other similar or related article, including a component part, or accessory which is either intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment or prevention of disease or intended to affect the structure of any function of the body of man or other animals, and which does not achieve its primary intended purposes through chemical action within or on the body."

Thus, because some of the applications are intended to be used "in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment or prevention of disease," they are regulated as medical devices.

But FDA also explained in its 2011 draft guidance document that it does not intend to regulate other applications, namely those applications that merely serve to record basic health functions (such as weight or caloric intake) but are not otherwise involved in disease-specific functions. They are, in other words, sort of the dietary supplements of the medical application world.

Questions Raised: What is a Medical Device?

But the regulatory framework constructed by FDA left legislators with a considerable number of questions, the most pressing of which related to the implementation of the 2.3% medical device excise tax that was passed under the Patient Protection and Affordable Care Act (PPACA), better known by some as "Obamacare."

FDA&nbsp;already regulates&nbsp;software and the medical devices on which they run, and considers them to be Class I medical devices requiring premarket notification. It has yet to weigh in on whether it considers a smartphone or tablet to be a medical device, though it already has the authority to regulate products that are used as an accessory or component part to a medical device. One might argue that when running a mobile medical application, a smartphone or tablet is rendered into a medical device.

If a smartphone or tablet is a medical device, that could, in theory, subject them to the terms of the medical device tax, or subject them to some sort of pre-market notification process.

And that potential taxation has left legislators in a state that is equal parts furious and curious, calling witnesses before the committee for a rare multi-day hearing focused on the products' potential, economic impact and regulatory framework.

FDA Responds: Chill Out

While many of the witnesses have testified that regulation and taxation would or will be a death knell for the fledgling but high-growth industry, FDA regulator Christy Foreman, director of the Office of Device Evaluation within the Center for Devices and Radiological Health (CDRH), had a very different interpretation of how her division regulates products.

"FDA believes it is important to adopt a balanced approach to mobile medical apps that supports continued innovation, assuring appropriate patient protection," Foreman said. "We also recognize that mobile health application developers and manufacturers need a clear, predictable, and reasonable understanding of the Agency's expectations."

A balanced approach is one that recognizes that some apps carry next to no risk, while others represent significant risks to other patients, she continued. Regulators have been increasingly aware of applications in recent months, particularly those sold in Apple's App Store, that make fraudulent and even dangerous claims to consumers. For example, an application that fraudulently claims to treat a condition-say, cancer-could prevent a consumer from actually seeking treatment for that condition, compounding the risks and harms to the patient.

Even when a device does what it is indicated to do, it still runs the risks associated with any other medical device, Foreman said.

"In some cases those risks are similar or identical to the risks associated with an already-marketed medical device. As an example, mobile apps that affect the programming of a drug infusion pump or computed tomography (CT) scanner could lead to a drug or radiation overdose. An inaccurate or malfunctioning mobile medical app that uses a sensor to diagnose skin cancer or to measure critically low blood oxygen levels in chronic lung disease patients, could delay lifesaving diagnosis and treatment."

What Won't be Regulated: Iterative Changes, Tablets or Smartphones

Foreman added that FDA "intends to use [its] authority reasonably and judiciously," noting that the agency has already made clear its enforcement discretion is limited to a "small subset of mobile apps" that meet the definition of medical device under the FD&amp;C Act.

"This narrowly tailored approach would not require active FDA oversight of many apps that would otherwise meet the definition of 'device,'" she added.

Foreman also sought to pacify critics, stating in clear terms that FDA "would not regulate the sale or general consumer use of smartphones or tablets &hellip; FDA's proposed mobile medical apps policy would not consider mobile platform manufacturers to be medical device manufacturers just because their mobile platform could be used to run a mobile medical app regulated by FDA."

In addition, "FDA's proposed mobile medical apps policy would not consider entities that exclusively distribute mobile medical apps, such as the owners and operators of the 'iTunes App store' or the 'Android market,' to be medical device manufacturers," she said.

Neither would FDA's regulatory framework call for each "minor, iterative product change" to be approved or cleared by FDA under its 510(k) premarket notification process.

Even if such a device meets the definition of a "medical device," FDA would not regulate it under its authority to exercise enforcement discretion, it said.

In the future, Foreman said, the agency plans to "maintain a publicly available website" listing all information regarding approved mobile medical applications cleared by the agency, as well as those the agency intends to exercise its enforcement discretion regarding.

In addition, Foreman said in an accompanying piece on its FDA Voice&nbsp;blog that the agency plans to release its final mobile medical app guidance "in coming weeks."